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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE Back to Search Results
Model Number EG29-I10C
Device Problems Electrical /Electronic Property Problem (1198); Optical Distortion (3000)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  malfunction  
Event Description
This event occurred at the time of during inspection.There was no report of patient harm.Iso failed ; misty image.
 
Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c is available in the usa with a 510k number k190805.Evaluation summary we checked the returned product and confirmed that we confirmed that a breakage of kapton tape wound around cmos unit inside the scope distal end.It caused that the electrical safety test in emea to fail.Regarding the misty image,it was caused due to a condensation of moisture in the ccd unit by changing the temperature outside of the endoscope.This report is being filed as part of the pentax backlog management plan.
 
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Brand Name
PENTAX
Type of Device
IMAGINA GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12351828
MDR Text Key283091283
Report Number9610877-2021-10535
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04961333248483
UDI-Public04961333248483
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 08/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG29-I10C
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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